Nerve Growth Factor

After seven years of challenging research, Dompé successfully engineered and manufactured the first recombinant human nerve growth factor (rhNGF).
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What is the nerve growth factor?

Nerve growth factor (NGF) was discovered by the Italian neurobiologist, Professor Rita Levi-Montalcini, and her colleague Dr. Stanley Cohen. For this discovery, they were awarded the Nobel Prize in Physiology or Medicine in 1986 (1).

Nerve growth factor (NGF) is an endogenous protein involved in the differentiation and maintenance of neurons. In their research, Drs. Levi-Montalcini and Cohen uncovered that NGF plays a crucial role in the proliferation, differentiation and survival of sympathetic and sensory neurons (1).

Dompé sets out on a journey to bring NGF to patients

At Dompé our goal is to improve the lives of patients living with challenging conditions. We strive to focus on areas of high unmet medical need.

2010 was a momentous year when Dompé acquired the rights to research NGF. Following several years of research, our committed team of scientists developed a recombinant protein of human nerve growth factor (rhNGF). It is produced using an innovative process that was developed to create a stable form of the NGF protein, by taking specific sequencing of NGF and forming the final molecule in prokaryotic cells.

These bacteria then produce a recombinant protein, which is structurally identical to the NGF protein naturally produced by the human body.

Having created this recombinant human nerve growth factor (rhNGF)-based drug, we then developed a production process that could produce the recombinant protein on an industrial scale. The complex production process of this biotech drug was set up at our L’Aquila production site in Italy.

The production process requires a team of highly skilled technicians and biotechnologists to manufacture rhNGF. A key challenge in the process is ensuring that the active ingredient is kept at very low temperatures within specially designed cold stores. Therefore, we also set up a cold chain to ensure that once produced, the drug is distributed to patients in containers kept at -20°C.

*Not an Actual Patient

The road ahead

We are currently investigating applications in other ocular diseases (2, 3).

Our success in ophthalmics (4) is only a stepping stone for rhNGF-based applications. We are now exploring potential opportunities to treat other diseases. We have expanded our research efforts into neurotrophins, including manufacturing, formulation, and administration, to better understand their potential for patients.

We believe that incremental innovation may lead to innovative solutions.

References

1. The Nobel Prize in Physiology or Medicine 1986 (https://www.nobelprize.org/prizes/medicine/1986/press-release/)

2. Lambiase A, Mantelli F, Sacchetti M, Rossi S, Aloe L, Bonini S. Clinical applications of NGF in ocular diseases. Arch Ital Biol.2011; 149(2):283-292. doi: 10.4449/aib.v 149i2. I 363 (https://pubmed.ncbi.nlm.nih.gov/21702001/ )

3. Lambiase A, Manni L, Bonini S, Rama P, Micera A, Aloe L. Nerve growth factor promotes corneal healing: structural, biochemical, and molecular analyses of rat and human corneas. Invest Ophthalmol Vis Sci. 2000;4 l (5): 1063-1069. (https://pubmed.ncbi.nlm.nih.gov/10752942/ )